RecruitingRecruiting
Definitive Radiation Therapy for Inoperable Breast Cancer
NCT07122713 · Stony Brook University
In plain English
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Official title
Multi-institutional Prospective Pilot Study of Definitive Breast Radiation Therapy for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
About this study
Patients who cannot undergo surgical resection for either breast cancer or local control of metastatic cancer have limited effective treatment options. Treatments typically employed in the adjuvant setting have been found in the definitive setting to be inferior to surgery followed by adjuvant therapy. This raises the necessity of evaluating the use of ablative doses of radiation to provide durable local control of the tumor in such patients. Indeed, there is growing evidence that RT is effective in the adjuvant setting. This is a study of concurrent ultra-hypofractionated whole breast whole breast radiation delivered via simultaneous integrated boost to the gross tumor for breast cancer patients not undergoing surgery.
Eligibility criteria
Inclusion Criteria:
* Biopsy proven invasive carcinoma of the breast, either lobular, ductal and/or no special type
* T1-T4, N0-2, M0-1 invasive breast carcinoma by radiological or clinical criteria
* Cancer is deemed unresectable, or the patient is a poor surgical candidate as determined following evaluation by a surgeon, or patient declines surgery.
* Life expectancy \> 6 months
* Negative pregnancy test at the time of start of treatment in any female of reproductive age
Exclusion Criteria:
* Concurrent systemic therapy (except for endocrine therapy, HER2-targeted therapy, or immunotherapy which are permitted)
* Prior radiation to ipsilateral breast or regional nodes
* Inability to receive study treatment planning and treatment secondary to body habitus
Study design
Enrollment target: 30 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-08
Estimated completion: 2033-12-30
Last updated: 2025-12-17
Interventions
Radiation: Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumorRadiation: Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodes
Primary outcomes
- • Treatment Safety (12 months)
Sponsor
Alexander Stessin · other
With: Northwell Health
Contacts & investigators
ContactCaterina Stony Brook Cancer Center Clinical Trials · contact · cancerclinicaltrials@sronybrookmedicine.edu · 631-728-7425
ContactCaterina Vacchi-Suzzi, PhD · contact · caterina.vacchi-suzzi@stonybrookmedicine.edu · 6312162993
InvestigatorAlexander Stessin, MD PhD · principal_investigator, Stony Brook University Hospital
All locations (1)
Stony Brook University Cancer CenterRecruiting
Stony Brook, New York, United States